In short
Clinical trials are investigating LY4170156, also called Sofetabart Mipitecan, in people with ovarian cancer and related cancers. This article explains what the trials are studying, who may join, and how the studies measure benefit and safety. The main goal is to compare LY4170156-based treatment with standard treatment options in different ovarian cancer groups.
Key points
- LY4170156 is being studied in a Phase 3 trial for people with ovarian cancer and related cancers. The study has two parts: one for platinum-resistant disease and one for platinum-sensitive disease. Researchers are comparing LY4170156-based treatment with standard treatment choices. The main outcome is progression-free survival, which shows how long the cancer does not get worse. The trial is authorised and plans to enroll 1,125 participants. The study also uses different review methods, including investigator assessment and blinded central review.
Trial overview
The main trial in the data is NCT07213804, a Phase 3 interventional study of LY4170156, also called Sofetabart Mipitecan, in ovarian cancer and related cancers.
The study is designed in two parts: Part A for platinum-resistant ovarian cancer and Part B for platinum-sensitive ovarian cancer.
Who is being studied
The trial includes people with ovarian neoplasms, fallopian tube neoplasms, peritoneal neoplasms, and neoplasm metastasis.
These names mean the cancer starts in the ovary, fallopian tube, or peritoneum, and in some cases has spread to another part of the body.
Part A focuses on people whose cancer is platinum-resistant, which means the cancer did not respond well to platinum treatment or returned soon after it.
Part B focuses on people whose cancer is platinum-sensitive, which means the cancer still responds to platinum-based treatment.
Treatments being compared
In Part A, the study compares Sofetabart Mipitecan (LY4170156) with the control arm, which is the investigator’s choice of chemotherapy or mirvetuximab soravtansine (MIRV).
In Part B, the study compares Sofetabart Mipitecan plus bevacizumab with the control arm of investigator’s choice platinum-based doublet chemotherapy plus bevacizumab.
These control arms show what standard treatment options the study is using for comparison, so researchers can see whether the LY4170156-based approach works better.
Study endpoints
The main outcome in Part A is progression-free survival (PFS) measured by RECIST v1.1 and assessed by the investigator.
The main outcome in Part B is progression-free survival measured by RECIST v1.1 and reviewed by blinded, independent, central review (BICR).
Progression-free survival means the time during and after treatment when the cancer does not get worse.
RECIST v1.1 is a standard method for measuring whether tumors grow, shrink, or stay the same.
BICR means independent experts review the results without knowing which treatment a person received, which helps make the comparison fair.
Trial status and size
The study status is Authorised, which means it has been approved to move forward.
The planned enrollment is 1,125 participants, showing that this is a large study.
The trial is interventional, meaning the researchers assign treatments and then measure the results.